Fees and charges: summary - from 1 July 2018

Version 1.1, October 2018

12 October 2018

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Clinical trials

The Clinical Trial Notification (CTN) and Clinical Trial Exemption (CTX) schemes provide two avenues for conducting clinical trials involving the use of unapproved therapeutic goods.

Unapproved medicines

These fees for clinical trials of unapproved medicines are in Part 2, Schedule 9, Therapeutic Goods Regulations 1990.

Unapproved medicines Fee Item in Schedule 9 Part 2
Clinical trial notification (CTN) $360 Item 14(a)
Clinical trial notification (CTN) - for each notification of one or more additional trial sites $360 Item 14(b)
Clinical trial exemption (CTX) - 30 day evaluation $1,720 Item 1(a)
Clinical trial exemption (CTX) - 50 day evaluation $21,500 Item 1(b)

Unapproved biologicals

These fees for clinical trials of unapproved biologicals are in Part 2, Schedule 9A, Therapeutic Goods Regulations 1990.

Biologicals Fee Item in Schedule 9A Part 2
Clinical trial notification (CTN) $360 Item 17(a)
Clinical trial notification (CTN) - for each notification of one or more additional trial sites $360 Item 17(b)
Clinical trial exemption (CTX) $26,100 Item 16

Unapproved medical devices (including IVDs)

These fees for clinical trials of unapproved medical devices and IVDs are in the Therapeutic Goods (Medical Devices) Regulations 2002.

Unapproved medical devices (including IVD) Fee Item in Schedule 5 Part 1
Clinical trial notification (CTN) $360 Item 1.8
Clinical trial exemption (CTX) $18,200 Item 1.7

Unapproved other therapeutic goods

These fees for clinical trials of unapproved other therapeutic goods are in Part 2, Schedule 9, Therapeutic Goods Regulations 1990.

Unapproved other therapeutic goods Fee Item in Schedule 9 Part 2
Clinical trial notification (CTN) $360 Item 14A(a)
Clinical trial notification (CTN) - for each notification of one or more additional trial sites $360 Item 14A(b)
Clinical trial exemption (CTX) - with no clinical studies to demonstrate safety and effectiveness $2,740 Item 1(d)
Clinical trial exemption (CTX) - with clinical studies to demonstrate safety and effectiveness $18,200 Item 1(c)

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